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  4. Annotated references required if accompanied by confirmation letter by Med Dept?
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Annotated references required if accompanied by confirmation letter by Med Dept?

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • NatBourreN Offline
    NatBourreN Offline
    NatBourre
    wrote on last edited by
    #1

    I realize we need a list of references for HCP-targeted information. Are we required to annotate the references if the medical department confirms in a letter that the content is accurate as per the references?

    Natalie Bourré
    Marketing 4 Health Inc.
    Medical Marketing Consultant, Medical Writer
    nat@marketing4health.net

    Jennifer CarrollJ 1 Reply Last reply
    0
    • NatBourreN NatBourre

      I realize we need a list of references for HCP-targeted information. Are we required to annotate the references if the medical department confirms in a letter that the content is accurate as per the references?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      @natbourre

      All materials should be reviewed and approved by the manufacturer’s medical department prior to submission to PAAB as per the efile submission form and Code section 1.6B3. However, this does not negate the requirement to annotate the references to facilitate PAAB review of the APS against advertising regulations. Please see our new guidance document for the submission process for directions on referencing.

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